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NCT Number: NCT02957838

Mitochondrial Effects of C18:0 Supplementation in Humans

The purpose of this crossover study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet and will then be supplemented with a bolus of C18:0. Changes in the mitochondrial morphology and function of white blood cells will be scored by immunofluorescence and FACS analysis.

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Key information

Conditions

Alteration of Mitochondrial Membrane Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fatty Acid Deficiency Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69123, Germany

About this study

The purpose of this study is to determine whether nutritional supplementation of C18:0 in humans has mitochondrial effects as shown in Drosophila and human cell culture. We will compare a study cohort of patients with diagnosed type 2 diabetes with non-diabetics. Participants will undergo a 2-day low-fat vegan diet to reach baseline levels of C18:0 and will then be fed a milkshake supplemented with 24g of C18:0, which corresponds roughly to the C18:0 content of a fast-food meal. Blood samples will be taken at baseline and several hours after intake. We will look at changes in mitochondrial morphology of neutrophils by immunofluorescence, and score mitochondrial function via FACS analysis. Since this study is designed as a crossover study, participants will also receive a mock milk shake after another 2 days of low-fat vegan diet.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetes, either dietary treatment or oral medication
  • must be able to give consent

Exclusion criteria

  • insulin treated diabetes mellitus
  • severe diseases inducing wasting (e.g. cancer, liver cirrhosis, renal failure)
  • conditions of malnourishment
  • severe anemia
  • pregnancy
  • alcohol abuse

Treatment and study plan

C18:0

Dietary Supplement

Receives 24g of C18:0 in a low-fat banana milkshake.

Other names: stearic acid, stearic acid, Sigma-Aldrich, product number W303518

mock

Dietary Supplement

Low fat banana milkshake without C18:0 supplement.

Primary outcomes

  1. Changes in Mitochondrial Morphology

    Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

    Mitochondria of neutrophils are stained and scored via immunofluorescence microcsopy, either as "fragmented", "intermediate" or "fused". Statistical calculations will be performed on changes in fragmentation status after treatment.

  2. Changes in Mitochondrial Function

    Time frame: on the day of supplementation at 0, 3 and 6 h

    Mitochondrial membrane potential and ROS production in neutrophils will be analyzed via FACS. Statistical calculations will be performed on changes in the respective levels after treatment.

Secondary outcomes

  1. plasma iron, transferrin, ferritin, ferroportin and hepcidin levels

    Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

    Measurement of iron, transferrin, ferritin, hepcidin and ferroportin from serum at all timepoints via ELISA. Changes in plasma levels will be correlated to primary endpoints.

  2. plasma methylglyoxal levels

    Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

    Methylglyoxal levels in plasma analyzed via liquid chromatography-mass spectrometry. Changes will be correlated to primary endpoints.

  3. plasma fatty acid levels

    Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

    Fatty acids along with other lipid parameters like triglycerides and cholesterol for normalization purposes will be measured.

  4. insulin resistance

    Time frame: 2 days before supplementation, on the day of supplementation at 0, 3 and 6 h

    Insulin and glucose levels will be measured at each time point, HOMA index will be calculated.

  5. diabetic late complications

    Time frame: 2 days before supplementation

    Patients with confirmed HbA1c > 6,5% will be considered diabetic. Then albumin in urine will be measured and diabetic neuropathy will be assessed clinically via NDS/NSS scoring.

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

  • German Cancer Research Center

Registry information

Official study title

Mitochondrial Effects of C18:0 Supplementation in Type 2 Diabetics Versus Healthy Controls

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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